BEUDAMED
    FDA Recall Terminated

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    Recall: Z-1714-2014 · Initiated May 12, 2014

    Recall

    Recall Number
    Z-1714-2014
    Event Number
    68363
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2014
    Posted
    June 4, 2014
    Terminated
    October 2, 2014
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    Reason

    Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

    Action

    Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail. The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form. Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.

    Distribution

    Nationwide Distribution including CA and IN

    Quantity

    2